(dailyRx News) GlaxoSmithKline has announced the FDA approved Lamictal ODT (lamotrigine) orally disintegrating tablets.
One factor physicians should consider when treating chronic disorders is whether patients can swallow the medications they need. In one large survey study, 23 percent of patients in a general practice setting reported difficulty swallowing.
"Patients with epilepsy or bipolar disorder can have difficulty swallowing tablets. Unfortunately, this problem may go unrecognized, because many patients don't discuss this issue with their healthcare providers," said Daniel Lieberman, M.D., associate professor and clinical director of the George Washington University Department of Psychiatry and Behavioral Sciences. "Orally disintegrating tablets, [such as] Lamictal ODT, offer an option for patients who have difficulty swallowing tablets."
Lamictal ODT was approved based on its demonstrated bioequivalence to Lamictal tablets. Lamictal ODT is the only anti-epileptic treatment available in an orally disintegrating formulation.
Lamictal ODT is indicated for the long-term treatment of bipolar disorder to lengthen the time between mood episodes in people age 18 and older who have been treated for mood episodes with other medicine. The drug is also used together with other medicines to treat certain types of seizures, including partial seizures, primary generalized tonic-clonic seizures and generalized seizures of Lennox-Gastaut syndrome, in people age 2 two and older or alone when changing from other medicines used to treat partial seizures in people age 16 years and older. It is not known if Lamictal ODT is safe or effective when used alone as the first treatment of seizures in adults.
Lamictal ODT will be available in 25 mg, 50 mg, 100 mg and 200 mg strengths in early July. For patients switching from Lamictal tablets to the ODT formulation, the recommended dose of Lamictal ODT matches the dose of Lamictal tablets. The medication will also be available in four maintenance packs, one pack for each dose strength. These packs each contain 30 tablets and are designed to help make it easy for patients to keep up with their daily dose.